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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fluorescence Polarization Immunoassay, Carbamazepine
510(k) Number K944063
Device Name FLUORESCENCE POLARIZATION IMMUNOASSAY CARBAMAZEPINE
Applicant
Sigma Diagnostics, Inc.
545 S. Ewing Ave.
St. Louis,  MO  63103
Applicant Contact HOYLE D HILL
Correspondent
Sigma Diagnostics, Inc.
545 S. Ewing Ave.
St. Louis,  MO  63103
Correspondent Contact HOYLE D HILL
Regulation Number862.3645
Classification Product Code
LGI  
Date Received08/19/1994
Decision Date 11/10/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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